Cleared Traditional

K790576 - QUANTIMUNE T-4 FIA

K790576 is the FDA 510(k) clearance for QUANTIMUNE T-4 FIA by Bio-Rad. It is a Class 2 Chemistry device (product code CDX) cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K790576 · Bio-Rad · Chemistry device
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Jul 1979
Decision
124d
Days
Class 2
Risk

K790576 is an FDA 510(k) clearance for the QUANTIMUNE T-4 FIA. Classified as Radioimmunoassay, Total Thyroxine (product code CDX), Class II - Special Controls.

Submitted by Bio-Rad (Mchenry, US). The FDA issued a Cleared decision on July 30, 1979 after a review of 124 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1700 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K790576 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1979
Decision Date July 30, 1979
Days to Decision 124 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 88d · This submission: 124d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CDX Radioimmunoassay, Total Thyroxine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1700
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CDX Radioimmunoassay, Total Thyroxine

All 68
Devices cleared under the same product code (CDX) and FDA review panel - the closest regulatory comparables to K790576.
AMES RIALYZE - CHROMATOGRAPHY TUBES
K800169 · Miles Laboratories, Inc. · Feb 1980
TETRABEAD - 125 T4 SOLID PHASE DIAG. KIT
K792188 · Abbott Laboratories · Nov 1979
VENTRE/SEP T4 TEST SET
K791368 · Ventrex Laboratories, Inc. · Sep 1979
AUTOPAK TEST DELIVERY SYSTEM
K790907 · Micromedic Systems · Jun 1979
CENTRIA T4 RIA TEST SET
K790800 · Ventrex Laboratories, Inc. · Jun 1979
NEONATAL TY AUTOPAK TEST DELIVERY SYSTEM
K790665 · Micromedic Systems · May 1979